Volume 6, Issue 6, June – 2021 International Journal of Innovative Science and Research Technology

ISSN No:-2456-2165

Formulation and Evaluation of Orodispersive Tablets

of “Ebastine” Using Natural Super Disintegrant by
Molecular Dispersion Technique
Arun Kumar*
Institute of Pharmaceutical Science and Research, Sohramau, Unnao, U.P. India
Postal Address: 17, Moh. Kachcha Katra, P.O. Tilhar, Distt. Shahjahanpur, U.P. India 242307

Shalini Singh Dr. Sambit Kumar Parida Dr. N. Trilochana

(Asst. Professor) (Director – Deptt. of Pharmacy) (Director – Deptt. of Pharmacy)
Institute of Pharmaceutical Science Prof., Institute of Pharmaceutical Institute of Pharmaceutical Science
and Research, Sohramau, Unnao, Science and Research, Sohramau, and Research, Sohramau, Unnao,
U.P. India Unnao, U.P. India U.P. India

Abstract:- Ebastine is a 2nd generation H1 receptor
antagonist that is mainly indicated for allergic rhinitis
and chronic idiopathic urticaria. In allergic conditions
the patient become panic and will have difficulty to
swallow tablet with a glassful of water. In such cases
Orodispersive tablets will be a good solution for patient
compliance and efficient dose regimen. Ebastine tablets
are available in different strength i.e. 10 mg and 20 mg.
The main objective of this project work was to developed
and designed an Orodispersive tablets (ODTs)
containing Ebastine 20 mg, using “Natural Super
Disintegrants’’ by molecular dispersion technique
including various pharmaceutical excipients with
different strengths to enhance patient compliance and
therapeutic value as compare with the available market
brands. Orodispersive Tablets of Ebastine were
formulated by molecular dispersion technique and using
Natural Superdisintegrants such as Agar and Guar gum
and other excipients like gelatin, sodium lauryl sulphate,
microcrystalline cellulose, sweetening agent as Sodium
saccharine, talc and magnesium stearate as lubricants,
clove oil and lemon flavor as flavoring agent. Drug -
excipients compatibility tests performed before start the
formulation. The selection and the rejection of excipients
for experimental formulation was considered after
getting the result of drug excipients compatibility study.
The flowability of the powder mixtures were evaluated
using Carr's index, Angle of Repose and the Hausner’s
ratio. The tablets were evaluated according to the
standards prescribed by British Pharmacopoeia like
weight variation, thickness, hardness, friability,
disintegration time, a simulated wetting test and in-vitro
dissolution. Prepared tablets after Optimization showed
disintegration time less than 30 seconds and drug
dissolution of about 75% within 30 minutes. The
prepared tablets of optimized batch tested for stability
40 degree Celsius and 75% RH for 3 months and were
found to be stable. Prepared Orodispersive tablets of
Ebastine 20 mg from optimized batch were found
bioequivalent under fasting and fed conditions with the
available market products. The determination and
evaluation were made for the most effective type and
optimal amount of “Natural Super Disintegrants’’ for
the manufacture of Orodispersive Tablets by molecular
dispersion & direct compression technique.
I. INTRODUCTION
Tablet measurements structure is the most well-known
medication conveyance frameworks which are viewed as the
least demanding and most reasonable method of
organization of the medication to a patient with the
utilization of a glass of water. So, tablets are the most best
measurements structure involves the biggest and the most
critical spot as contrast with other dose structures. There are
various sizes relating to the portion of the medication which
can be given just as the state of the tablet. A few tablets may
contain as low as 1 mg or less of the medication, and others
contain 1.5 g. of the dynamic medication per tablet, which
gives an immense scope of medication content. Tablet dose
structures can be made in various sizes and shapes, and the
medication fixing may contain 0.1% to 90% of a tablet
mass. The assembling of tablets is very simple when
contrasted with other measurements structure. The
soundness issues are extremely less too. Creation yield is
likewise high and is the most affordable. Especially in the
event of present-day mechanical strategies including the
cycle of Direct Compression Technique (DC).
Direct Compression is the most straightforward,
monetary and financially savvy producing procedure which
would now be able to be applied to Orodispersive tablets,
Fast dissolving Tablets, Mouth dissolving tablets and so on
due to the accessibility of huge scope of exceptionally
improved excipients like tablet normal super disintegrants,
semi engineered disintegrants, manufactured excipients,
strands and sugar-based excipients.

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Volume 6, Issue 6, June – 2021 International Journal of Innovative Science and Research Technology
"Orodispersive Tablets" (ODTs) can be characterized
as strong single-unit measurement structure that is expected
to be set on the tongue where it disintegrates quickly within
the sight of salivation inside couple of moments and
afterward gulped without the need of water. Quicker the
medications breaking down, scattering and disintegration
happen, the faster the ingestion and beginning of clinical
impact.
As indicated by the US-FDA, the ODTs were
characterized as "A strong measurements structure
containing restorative substances which breaks down
quickly, for the most part inside only seconds, when set
upon the tongue". It has been demonstrated measurably that
(ODTs) have a few focal points over regular tablets to
upgrade persistent consistence and acknowledgment in light
of its attainability and comfort. Practically half of the
populace experiences trouble gulping while at the same time
taking traditional tablets and hard gelatin containers. These
populaces incorporate pediatric and geriatric populaces who
experience issues gulping enormous tablets. So as to defeat
these issues, Orodispersive tablets (ODTs) have been
created as elective oral measurements structures. Likewise,
ODTs turned into a phenomenal decision as another
medication conveyance framework, since they are anything
but difficult to regulate and prompt better patient
consistence, particularly in the older and kids.
The goal of this investigation was to create and plan an
Orodispersive tablet dose type of dynamic medication
Ebastine, utilizing different drug organizations including
super disintegrants from characteristic sources to improve
tolerant consistence basically for pediatric and geriatric
patients. It is a histamine-H1 receptor obstructing specialist
with anticholinergic and narcotic property utilized for its
insect unfavorably susceptible properties. Consequently, it is
basically utilized in the administration of hypersensitivity
manifestations like unfavorably susceptible rhinitis,
urticaria, skin rashes, irritated/watery eyes, runny nose, and
regular virus.
In the current investigation, Orodispersive tablets
(ODTs) of Ebastine was planned utilizing Natural
Superdisintegrants by molecular dispersion technique.
II. MATERIAL AND METHODS
Drug and Excipients used in the formulation
Material
Ebastine
Gelatin
Sodium Lauryl Sulphate
Agar
Guargum
Microcrystalline Cellulose
Sod. Saccharine
Clove Oil
Lemon Flavor
Colloidal Silicon-di-Oxide
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ISSN No:-2456-2165
Direct compression method was applied to compress the
tablets due to generally helpful, straightforward, savvy. The
excipients were utilized in the detailing, for example,
Gelatin, Sod. Lauryl sulfate, Agar, Guar gum,
microcrystalline cellulose, Sod. Saccharine, Colloidal
Silicon di oxide and magnesium stearate. The planned tablet
definitions will be assessed for as indicated by the British
Pharmacopeia for weight variety, thickness, hardness,
friability, breaking down time, a recreated wetting test, and
in-vitro disintegration. The dependability of test item was
assessed according to the ICH Q8 rules.
Justification of Research
Super disintegrants are the key material for a
successful brand and the best therapeutic results in the form
of Orodispersive tablets. The existing market brands
containing Ebastine 20 mg or 10 mg were developed and
designed using superdisintegrants obtained from other than
natural sources or synthetic sources. In the current research
work it has been proven that natural superdisintegrants are
superior as compared to superdisintegrants obtained from
synthetic process. Commercially, the Natural
Superdisintegrants are freely available in market. The price
of Natural superdisintegrants are very competitive and
cheaper than synthetic superdisintegrants. Although the
superdisintegrants obtained from natural sources categorized
safer ingredients in comparison to synthetic
superdisintegrants. The molecular dispersion technique
utilized to increase the bioavailability of active constituent
‘Ebastine’ which is poorly soluble in water. Molecular
dispersion of micronized form of Ebastine with gelatin and
Sodium Lauryl Sulphate increased its solubility which get
dissolved faster in presence of Natural superdisintegrants
when comes in contact with saliva after placing the tablet in
oral cavity and get quick absorbed in blood stream. The
onset of action of drug start faster than a conventional tablet.
The preparation of Orodispersive tablets using Natural
superdisintegrants by Molecular dispersion technique is
completely satisfies the regulatory requirements and the
manufacturing process is commercially feasible. The
optimized formulation was robust, following all the
parameters of standards and no issues were faced with
respect to organoleptic attributes, blend uniformity, content
uniformity, tableting, stability and bioequivalence etc.
Gifted By
Bal Pharma Ltd.
Bal Pharma Ltd.
Bal Pharma Ltd.
Bal Pharma Ltd.
Bal Pharma Ltd.
Bal Pharma Ltd.
Bal Pharma Ltd.
Bal Pharma Ltd.
Bal Pharma Ltd.
Bal Pharma Ltd.
929
 Volume 6, Issue 6, June – 2021
Equipment and instruments used during formulation
Equipment and instruments
Weighing Machine
Vibrosifter
Electromagnetic Sieve Shaker
Tap Density Testing Apparatus;
Double Cone Blender with interchangeable bowls
Loss on Drying Mositure Analyzer
Comminuting Mill equipped with 0.5mm Screen
16 Station Single Rotary Tablet Compression
Machine
Hardness Tester
Thickness Tester Vernier Caliper
Friabilator
Disintegration Test Apparatus
6.35 mm Round Flat Faced Bevel Edged Punch
Tooling
pH Meter
UV Visisble Spectrophotometer
Lab Stirrer
Dissolution Apparatus
40°C / 75% RH Stability Chamber
Disintegration and dissolution parameters
Disintegration test was performed in USP
disintegration test apparatus in purified water at 37+ 0.5-
degree celcius. Specification NMT 30 Seconds. Dissolution
is performed in purified water. The parameters include USP-
II (Paddle) 50 RPM, 900 ml, purified water at 37+ 0.5-
degree celcius, Time Points 0, 0.08, 0.16, 0.25, 0.33, 0.41,
0.5, 0.66, 0.83, 1.0, 2.0, 4.0 and 6.0 minutes. Specification
NLT 75% (Q) of the labelled amount in 60 minutes.
III. METHOD OF ASSAY, BLEND UNIFORMITY,
CONTENT UNIFORMITY/UNIFORMITY OF
DOSAGE UNITS AND DISSOLUTION
Method for Bulk Density, tapped density, Angle of
Repose and Friability
USP guidelines followed in the measurement of Bulk
Density, Tapped Density, Compressibility Index, Hausner’s
Ratio, Repose Angle and % Friability measurements.
Experimental Methodology
Molecular dispersion technique with micronized active
drug Ebastin by using Natural superdisintegrants, the
process will be the same for every trial batch from Batch
No. F1 – Batch No. F13 for the manufacturing of
Orodispersive Tablets.
 Step -1: - Material Sifting
o Ebastin, Sod. Lauryl Sulphate, Guar gum, Agar,
Microcrystalline Cellulose shall be sifted through #60
separately.
o Colloidal silicon dioxide and Magnesium Stearate shall
be sifted through #60 separately.
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International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
Make and Model
PS6000/C/1 manufactured by LCGC RADWAG
Gansons Engineering
EM8-08 Plus manufactured by Electrolab
ETD-1020 manufactured by Electrolab
manufactured by Sams Technomech;
Model MB 45 manufactured by Ohaus
Manufactured by Cadmach Machinery;
Manufactured by Cadmach Machinery
Type: TBH 125 manufactured by Erweka
Absolute Dogmatics manufactured by Mitutoyo
EF-1W manufactured by Electrolab
Model ED 2L manufactured by Electrolab
manufactured by ACG PAM Pharma Technology
H12215 manufactured by Hanna Instruments
manufactured by Perkin Elmer Lambda 25
RQ126D manufactured by Remi
TDT-08L manufactured by Electrolab
manufactured by Thermolab Scientific Equipment
 Step – 2:- Manufacturing Process
o Take Gelatin and SLS in a china dish according to the
formula and melt at 70 degrees Celsius.
o Now transfer the whole qty of Ebastin into china dish
and mix properly.
o Keep the homogenous mixture in a refrigerator for 5-8
hrs.
o Cooled mass shall be milled and mixed with previously
sifted MCC, Agar/Guar gum and blend until proper
mixing of all ingredients.
 Step - 3:- Lubrication
o Finally add previously sifted colloidal silicon dioxide,
Mag. Stearate, Sod. Saccharine, Flavors and lubricate for
5 min.
 Step – 4:- Compression
o The lubricated blend is compressed into tablets as per
pre-planned formulation by using a rotary compression
machine.
 Step – 5:- Analysis
o Compressed tablets shall be analyzed as per the official
guidelines for all parameters and a comparative study
shall be done with the existing market brand
Parameters Fixed for the tablet
The following parameters were mixed for the final
tablets obtained:
 Punch size: 7.14 mm
 Thickness: 3.2 – 3.6 mm
 Hardness: 20 – 100 Newton
 Weigh variation: +/- 2 %
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Proposed Formulations For Experiments

(Table 1.0) F1-F6 with Natural Superdisintegrants alone

Unit Formula (mg/tablet)
Sr. No. Ingredients
F-1 F-2 F-3 F-4 F-5 F-6
1 Ebastine 20 20 20 20 20 20
2 Gelatin 1.5 1.5 1.5 1.5 1.5 1.5
3 Sodium Lauryl Sulphate 1.5 1.5 1.5 1.5 1.5 1.5
4 Agar 5 -- 9 -- 13 --
5 Guargum, -- 5 -- 9 -- 13
6 MCC 117 117 113 113 109 109
7 Sod. Saccharine 2 2 2 2 2 2
8 Colloidal Silicon-di-oxide 1.5 1.5 1.5 1.5 1.5 1.5
9 Mag. Stearate 1.5 1.5 1.5 1.5 1.5 1.5
Net Wt. / Tab. in mg 150 150 150 150 150 150

(Table 2.0) F7-F9 with the combination of 2 Natural Super disintegrants

Unit Formula (mg/tablet)
Sr. No. Ingredients
F-7 F-8 F-9
1 Ebastine 20 20 20
2 Gelatin 1.5 1.5 1.5
3 Sodium Lauryl Sulphate 1.5 1.5 1.5
4 Agar 3 5 9
5 Guargum* 3 5 9
6 MCC 116 112 104
7 Sod. Saccharine 2 2 2
8 Colloidal Silicon-di-oxide 1.5 1.5 1.5
9 Mag. Stearate 1.5 1.5 1.5
Net Wt. / Tab. in mg 150 150 150

(Table 3.0) F10-F13 with organoleptic additive

(After getting results of previous formulations from F1 – F9)
Unit Formula (mg/tablet)
Sr. No. Ingredients
F-10 F-11 F-12 F-13
1 Ebastine 20 20 20 20
2 Gelatin 1.5 1.5 1.5 1.5
3 Sodium Lauryl Sulphate 1.5 1.5 1.5 1.5
4 Agar 9 9 9 9
5 Guar gum, 9 9 9 9
6 MCC 101 101 101 101
7 Sod. Saccharine 2 2 2 2
8 Clove Oil 2 -- 3 --
9 Lemon Flavor -- 2 -- 3
10 Colloidal Silicon-di-oxide 1.5 1.5 1.5 1.5
11 Mag. Stearate 1.5 1.5 1.5 1.5
Net Wt. / Tab. in mg 150 150 150 150

Preformulation studies
All the excipients were evaluated with the drug for compactability studies. The preformulation studies were performed
according to the formula and results were recorded based on the data was obtained accordingly.

Characterization of Active Drug

The active drug was evaluated for various parameters through the standard test and accordingly the results have been
mentioned in Table 4.0

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Table 4.0 Result analysis of Ebastine
Test Specification Observation Conclusion
Description White color powder White color powder Complied
Odor Odorless Odorless Complied
Solubility Insoluble in water Practically Insoluble in water Complied
Sparingly soluble in methyl alcohol; Practically it is sparingly soluble in methyl alcohol; Complied
freely soluble in methylene chloride. freely soluble in in methylene chloride.

Drug-excipient compatibility studies

The drug was evaluated along with all the excipients for compatibility studies and the results were recorded as per the data
obtained after completion of the studies in Table 5.0.

The FT-IR spectrum of Ebastine and excipient individually and their mixtures of drug and excipient are shown in Fig. 1.0 to
1.10

Table 5.0 Drug-excipient compatibility data

S. No. Drug+ Excipient Condition
Room Hot air oven Freezing
Temperature Temperature
1 EBASTINE (API)* Stable Stable Stable
2 API + GELATIN Stable Stable Stable
3 API + SODIUM LAURYL SULPHATE Stable Stable Stable
4 API + MCC Stable Stable Stable
5 API + AGAR Stable Stable Stable
6 API + GUAR GUM Stable Stable Stable
7 API + COLL. SILI. DI. OXIDE Stable Stable Stable
8 API + MAG. STEARATE Stable Stable Stable
9 API + SOD. SACCHARINE Stable Stable Stable
10 API + CLOVE OIL Stable Stable Stable
11 API + LEMON FLAVOR Stable Stable Stable

Fig. 1.0 FT-IR spectrum of “EBASTINE’’

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Volume 6, Issue 6, June – 2021 International Journal of Innovative Science and Research Technology
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Fig. 1.1 FT IR spectrum of API+GELATIN

Fig. 1.2 FT IR spectrum of API + SODIUM LAURYL SULPHATE

Fig. 1.3 FT IR spectrum of API+AGAR

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Fig. 1.4 FT IR spectrum of API+GUARGUM

Fig. 1.5 FT IR spectrum of API+MICRO CRYSTALLINE CELLULOSE

Fig. 1.6 FT IR spectrum of API + COLLOIDAL SILICON DIOXIDE

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Volume 6, Issue 6, June – 2021 International Journal of Innovative Science and Research Technology
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Fig. 1.7 FT IR spectrum of API + MAGNESIUM STEARATE

Fig. 1.8 FT IR spectrum of API + SODIUM SACCHARINE

Fig. 1.9 FT IR spectrum of EBASTINE + CLOVE OIL

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Volume 6, Issue 6, June – 2021 International Journal of Innovative Science and Research Technology
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Fig. 1.10 FT IR spectrum of API + LEMON FLAVOUR

Determination of λmax of Ebastine using a UV spectrometer

The λmax of Ebastine was found to be 252 nm.

Results of pre-compression studies

Precompression studies generally involve the evaluation of the blend in terms of bulk density, tapped density,
compressibility index, Hausner's ratio, and so on (Table 5.3). These also determine the flow property of the powder.

Table 6.0 Physical properties of the prepared blend

BATCH BULK TAPPED ANGLE OF CARR’S INDEX HAUSNER’S
DENSITY DENSITY REPOSE RATIO
F1 0.49+0.002 0.65+0.001 31.96+0.38 24.62 + 0.160 1.33+ 0.003
F2 0.45+0.001 0.60+0.001 32.49+0.80 25.00 + 0.660 1.33+ 0.003
F3 0.49+0.001 0.69+0.001 32.58+0.46 28.99 + 0.360 1.41+ 0.009
F4 0.51+0.002 0.70+0.001 34.81+0.86 27.14 + 0.890 1.37+ 0.016
F5 0.53+0.001 0.71+0.001 34.58+0.58 25.35 + 0.450 1.34+ 0.014
F6 0.52+0.002 0.69+0.001 34.31+0.36 24.64 + 0.860 1.33+ 0.006
F7 0.55+0.001 0.71+0.001 32.58+0.46 22.54 + 0.360 1.29+ 0.009
F8 0.53+0.002 0.73+0.001 34.81+0.86 27.40 + 0.890 1.38+ 0.016
F9 0.50+0.001 0.71+0.001 34.58+0.58 29.58 + 0.450 1.42+ 0.014
F10 0.55+0.002 0.69+0.001 34.31+0.36 20.29 + 0.860 1.25+ 0.006
F11 0.52+0.001 0.73+0.001 34.58+0.58 28.76 + 0.450 1.35+ 0.014
F12 0.52+0.002 0.68+0.001 34.31+0.36 23.53 + 0.860 1.31+ 0.006
F13 0.51+0.001 0.71+0.001 32.58+0.46 28.17 + 0.360 1.39+ 0.009

Results of post compression studies

Orodispersive tablets of all set of batches were evaluated after the compression for several pre-prescribed pharmacopeial and
in-house standards and parameters like average weight, Hardness, Friability, Drug Content, Tablet thickness, dispersion, drug
content, wetting time, water absorption ratio, and in vitro disintegration time.
 After the completion of analytical tests, the obtained results are shown in Table 7.0 and 8.0.
 In-vitro dissolution rate study is shown in Table. 9.0.

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Table 7.0 Evaluation parameter of the tablet
BATCH Average weight Hardness Friability Drug content Thickness
(mg)* (N)** (%) (%)** (mm)
F1 148.99 34.8±4.57 0.89 98.57 3.26±0.05
F2 149.00 36.8±4.87 0.46 100.52 3.23±0.02
F3 150.02 36.8±2.67 0.51 101.18 3.44±0.04
F4 150.50 41.8±3.17 0.49 102.73 3.34±0.04
F5 151.40 39.8±2.58 0.79 101.34 3.46±0.03
F6 150.20 38.8±3.87 0.76 100.48 3.45±0.04
F7 150.02 36.8±2.67 0.70 99.88 3.24±0.04
F8 150.50 42.8±3.17 0.57 99.43 3.34±0.04
F9 149.40 39.8±2.58 0.59 101.24 3.36±0.03
F10 150.20 37.8±3.87 0.36 100.48 3.35±0.04
F11 150.50 43.8±3.17 0.87 101.33 3.54±0.04
F12 151.40 39.8±2.58 0.49 101.24 3.46±0.03
F13 150.20 37.8±3.87 0.86 99.68 3.34±0.04
* Average weight of 20 tablets was taken into consideration ** Average of 3 readings

Table 8.0 Evaluation parameter of the tablet

Batch Wetting Time (Sec.) Disintegration Time (Sec.)
F1 0.87±0.052 17.0±1.00
F2 2.17±0.032 14.0±1.50
F3 0.67±0.352 17.0±1.20
F4 0.68±0.042 30.0±1.80
F5 0.97±0.059 29.0±1.80
F6 0.67±0.012 23.0±2.10
F7 2.17±0.032 25.0±1.50
F8 0.67±0.352 15.0±1.20
F9 0.47±0.059 12.0±1.80
F10 0.67±0.012 27.0±2.10
F11 0.67±0.012 29.0±2.10
F12 2.17±0.032 19.0±1.50
F13 0.67±0.352 16.0±1.20
**Average of 3 readings

In-Vitro Dissolution Study Results

The result of in vitro dissolution study is given in below Tables

Table 9.0 In-Vitro Dissolution Rate Study

Cumulative Percent Drug Release of All Formulation
Time AGAR AGAR AGAR GUAR GUM GUAR GUM GUAR GUM
(min) (F1) (F2) (F3) F4) (F5) (F6)

0 0 0 0 0 0 0
0.08 4.43±1.96 4.63±1.16 5.93±1.26 5.86±2.96 6.40±0.96 6.43±1.26
0.16 6.43±2.47 6.83±1.47 6.83±1.42 6.93±2.47 7.43±2.47 669±3.67
0.25 13.01±2.19 21.01±1.11 16.01±2.69 6.01±0.19 11.01±2.19 7.96±2.34
0.33 30.27±0.73 42.17±0.13 45.27±1.13 8.07±2.73 14.27±9.78 9.57±9.94
0.41 48.79±8.55 53.79±4.55 63.79±8.55 12.79±7.55 20.79±8.55 15.79±8.55
0.5 71.88±5.49 75.88±6.49 78.88±5.49 16.88±2.49 28.88±1.49 34.88±8.49
0.66 83.95±3.20 87.95±4.60 87.95±3.20 23.95±7.20 51.95±8.20 49.95±6.20
0.83 90.82±2.45 97.82±1.45 92.82±2.45 38.82±5.45 62.82±2.45 66.82±8.45
1 91.40±1.32 92.50±3.32 96.40±1.32 54.40±1.32 74.40±8.32 79.40±7.82
2 96.74±4.89 99.74±1.8 99.74±4.89 79.74±2.89 97.74±9.89 80.74±9.89
4 100.19±5.50 101.19±1.50 101.11±1.50 86.19±1.5 100.1±7.5 87.19±8.5
6 100.9±6.03 102.9±1.03 102.2±7.03 98.9±3.03 101.9±3.03 94.9±0.03
*Average of 2 reading

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Market Presence
Brand Name: Ebal 20
Dosage Forms: Fast Dissolving Tablets
Manufacturer: Bal Pharma Ltd.
IV. CONCLUSION
The Orodispersive tablets of Ebastine were
successfully formulated using various ratios of different
types of natural super disintegrants and the formulation was
prepared by molecular dispersion and direct compression
technique. The natural super disintegrants Agar and
Guargum were added in the formulations in various
concentrations to achieve the optimized batch. The
Orodispersive tablets of Ebastine were prepared using
natural super disintegrants along with the other excipients.
All the set of product formulation (F1-F13) were evaluated
for
 Pre formulation parameters such as Drug-excipients
compatibility studies.
 For flowability and compressibility analysis pre-
compression parameters such as Bulk & Tapped density
of blend, Carr’s index, Hausner’s ratio, and angle of
repose obtained.
 Initially, the powder blend for all set of batches was
evaluated for their flowability property. The values
obtained through Carr’s index were satisfactory
suggested that the blends have good compressibility and
the values obtained by Hausner’s ratio were showing a
good sign for flow property for the powder blend.
 Other tests like weight variation, hardness, friability,
disintegration time, wetting time, dissolution analysis,
drug content uniformity was performed as post-
compression parameters study.
 Finally, the optimized batch was also evaluated for
accelerated stability studies & bio equibalance study.
Orodispersive tablets of Ebastine were formulated to
have the adequate mechanical strength to withstand during
their handling, packaging, shipping, storage, and
transportation. The tablets were prepared following the
standards as prescribed by guidelines. Formulation F9 were
showing fast disintegration and dissolution profile. Drug
dissolution further impact on bioavailability and therapeutic
effect of formulation. The optimized formulation was
considered for stability studies. The data obtained from
stability studies demonstrated that Orodispersive tablets of
Ebastine were steady and stable under various natural
environmental storage conditions.
SUMMARY
Orodispersive Tablets (ODTs) drug-delivery systems
were developed for patient compliance, especially for
pediatric, geriatric, dysphagia, tremor, or physically disabled
and travelers. Sometimes it is impractical to access water
which is required to administer the drug in the form of a
tablet or capsules. Those patients who feel difficulty in
IJISRT21JUN839 www.ijisrt.com
International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
swallowing or engaged at such places where it is not easy to
approach water supply. Sometimes the patients may be in a
condition like the unconscious, travelers, minors, or old
aged so fast disintegrating tablets may resolve such issues to
administer the dose without providing them a sense to
swallow a drug. Such patients can be given a single tablet to
keep it in their mouth where the Orodispersive tablet is
dispersed in a few seconds and starts to absorb in the
bloodstream.
Orodispersive tablets are developed and designed for
quick dispersion and rapid disintegration in the saliva
generally less than 30 seconds. ODTs having some major
advantages over other formulations. ODTs disintegrate
quickly in saliva within few seconds and this is an advantage
that there is no need to take water.
There were mainly two techniques used to develop
ODTs
 The first technique is to use super disintegrants like
croscarmellose sodium (CCS), sodium starch glycolate
(SSG), crospovidone & other polymers as disintegrants.
 And the second technique is increasing the pore size
within tablets by freeze-drying or vacuum drying
process.
In this present research, Superdisintegrants were used
from Natural origin. Pre gastric absorption and quick
absorption of the drug from an oral cavity after the
dispersion of ODTs in saliva may increase the therapeutic
value or bioavailability of drugs. The test formulation
containing Ebastine as a model drug is a second-generation
H1 receptor antagonist. Ebastine is an ethanolamine
derivative H1 blocker. It competes with the free histamine to
bind at the HA receptor site. After placing an Orodispersive
tablet in the oral cavity, it disintegrates within a few seconds
and quickly gets absorbed in the blood. Orodispersive
tablets of Ebastine after oral administration has an onset of
action within a few minutes which is present for the next 10-
12 hrs. The elimination of the drug is by the renal and
metabolic routes. So it is important to reduce the dose of the
drug for patients having metabolic disorders, kidney, or
renal failure.
Orodispersive Tablets (ODTs) of Ebastine were
prepared by using natural super disintegrants with different
concentrations such as Agar, Guar gum. Gelatine, Sodium
lauryl sulfate, Micro Crystalline Cellulose, Sodium
saccharine, Lemon Flavor, Clove Oil, Colloidal silicon
dioxide, Magnesium Stearate were used in formulations as
other excipients. A total of 13 formulations were designed
with molecular dispersion. To compress Orodispersive
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tablets, the direct compression method was preferred. All the
set of batches were evaluated for Pre formulation parameters
like
Precompression Studies
 Drug excipients compatibility studies, Angle of repose
for flowability of powder blend, bulk, and tapped
density of powder blend, compressibility index,
Hausner's ratio was analyzed for each formulation.
Compression Parameters Studies
 Similar conditions were followed for all the sets of
formulations. The average weight of Orodispersive
tablets was within the range of 149.99 to 150.4 mg.
 Other parameters were found within the prescribed
limits such as weight variation, friability within the
range 0.36 – 0.89 % of all formulation.
 The hardness of tablets from all set of 13 batches was
found satisfactory and within the range of 34.8 to 43.8
Newton.
 Disintegration time is most of the important parameter
for ODT’s, quick dispersion or disintegration help in
swallowing of dispersed tablets & drug absorption in the
oral cavity, thus promoting therapeutic value by
increasing bioavailability of the drug.
 ODTs showing disintegration time within the time limit.
Practically the values were observed within the range of
12 sec to 30 seconds. The percent drug content of the
Orodispersive tablet of formulation F9 was found to the
98.57%, which has the best percent drug content among
all the sets of formulations & Formulation F4 was found
with the percent drug content of 54.40%, which has the
least percent drug content among all the formulations. In
vitro dissolution studied of ODT’s was performed in the
0.1N HCL using the USP paddle-type dissolution
apparatus. It was observed that formulations with the
natural super disintegrants in optimum concentration
having better drug release as compared to the product
with super disintegrants from synthetic sources due to
the swelling and wicking effect of its combination. The
best in-vitro dissolution profile was obtained from the
formulations containing super disintegrants from the
natural origin when the results were compared with the
preexisting formulations containing super disintegrants
from the synthetic origin. The optimized batch F9 was
considered for a long time on stress conditions to
determine the shelf life of the product.
FUTURE PROSPECTS OF CURRENT RESEARCH
WORK, BIOEQUIVALENCE STUDY AND CLINICAL
TRIAL
The prospects of Orodispersive formulations are
promising and the market demand is increasing day by day.
Several techniques were applied with different kinds of
material that were used to formulate the ODTs. Natural
Superdisintegrants are the best option to produce
satisfactory and safer ODT formulation which has been
IJISRT21JUN839 www.ijisrt.com
International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
proven with the existing study. ODTs with natural super
disintegrants were found stable during Drug Excipients
stability studies. Disintegration time and dissolution profiles
were found more challenging as compared with the available
ODTs with synthetic disintegrants. The optimized batch can
be considered for human trials to investigate the In-vivo
drug release. Bioequivalence studies can be done for test
formulation with the brand drug “Ebay 20” or with other
brands as available in the market.
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